UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038382 |
|---|---|
| Receipt number | R000043490 |
| Scientific Title | A phase II study of functional image-guided intensity-modulated radiotherapy for unresectable locally advanced lung cancer |
| Date of disclosure of the study information | 2019/10/25 |
| Last modified on | 2021/01/22 07:29:15 |
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Basic information
Public title
Functional image-guided intensity-modulated radiotherapy for unresectable locally advanced lung cancer
Acronym
FIGURE study
Scientific Title
A phase II study of functional image-guided intensity-modulated radiotherapy for unresectable locally advanced lung cancer
Scientific Title:Acronym
FIGURE study
Region
| Japan |
Condition
Condition
non-small cell lung cancer
Classification by specialty
| Pneumology | Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the safety and efficacy of functional image-guided intensity-modulated radiation therapy(IMRT) in patients with unresectable stage IIB-IIIC non-small cell lung cancer, and show whether Grade 3 or higher radiation pneumonitis become less frequent.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The incidence of Grade 3 or higher radiation pneumonitis(Common Terminology Criteria for Adverse Events ; CTCAE ver. 5.0) within 1 year after IMRT.
Key secondary outcomes
overall survival, progression-free survival, Grade 3 or higher adverse effects other than radiation pneumonitis, the relationship between dose-volume histogram(DVH) parameters and Grad 2, 3 or higher radiation pneumonitis, pulmonary function at 1 year after IMRT
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Functional image-guided IMRT 60-66Gy in 30-33 fractions
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Histologically or cytologically confirmed Non small cell lung cancer
2. Unresectable or refusing surgery
3. Clinical stage IIB-IIIC (UICC 8th edition)
4. Aged 20-85 years old.
5. Eastern Cooperative Oncology Group(ECOG) performance status of 0-2.
6. No previous tehrapy, such as chemotherapy, surgery, radion therapy, immune therapy for lung cancer.
7. Sufficient organ functions; fulfilling all of the following conditions within 28 days;
(i) White blood cell:3000/mm3 or more
(ii) Hemoglobin:8.0 g/dl or more
(iii) Platelet:50000/mm3 or more
(iv) Total bilirubin:2.0 mg/dl or less
(v) Serum creatinine:2.0 mg/dl or less
(vi) FEV1.0:700 ml or more
(vii) SpO2 (room air):90% or more
8. Written informed consent.
Key exclusion criteria
1. Synchronous or metachronous (within 3 years) malignancies.
2. Active infection requiring systemic therapy.
3. Body temperature of 38 or more degrees Celsius.
4. Women during pregnancy or possible pregnancy, within 28 days after delivery, or during breast feeding.
5. Severe mental disease.
6. Receiving continuous systemic steroid or immune-suppressive medication.
7. Idiopathic pulmonary fibrosis on CT.
8. Severe cough requiring narcotic drugs.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Tomoki |
| Middle name | |
| Last name | Kimura |
Organization
Kochi University Hospital
Division name
Radiation Oncology
Zip code
783-8505
Address
Kohasu, Oko-cho, Nangoku-shi, Kochi
TEL
088-880-2367
tkkimura@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuki |
| Middle name | |
| Last name | Imano |
Organization
Hiroshima University Hospital
Division name
Radiation Oncology
Zip code
734-8551
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
TEL
082-257-1545
Homepage URL
imano@hiroshima-u.ac.jp
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and technology of Japan
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Hiroshima University
Address
1-2-3, Kasumi, Minami-ku, Hiroshima
Tel
082-257-5555
iryo-seisaku@office.hiroshima-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 25 | Day |
Last modified on
| 2021 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043490
